Cleared Traditional

K922897 - STRAPPAL

K922897 is an FDA 510(k) clearance for STRAPPAL, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K922897 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
91d
Days
Class 1
Risk

K922897 is an FDA 510(k) clearance for the STRAPPAL. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on September 15, 1992 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K922897

510(k) Number K922897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date September 15, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGX Tape And Bandage, Adhesive

All 89
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K922897.
TISSUE ISOLATION AND RETRIEVAL BAG
K931886 · Advanced Surgical, Inc. · Sep 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993
ISOPORE(TM) TAPE, MODIFICATION
K925384 · Lectec Corp. · Apr 1993
ISOPORE TAPE
K922959 · Lectec Corp. · Sep 1992
LUEKOFLEX SURGICAL TAPE
K923404 · Beiersdorf, Inc. · Sep 1992
DEROYAL EYE DRESSING
K923300 · Deroyal Industries, Inc. · Sep 1992